A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors
ConditionSolid Tumors (Phase 1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd
About this trial
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
Eligibility criteria
Qualifiers
1. Patients should understand, sign, and date the written informed consent form before screening.
2. Male or female aged 18 years or older.
3. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type.
4. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing.
Disqualifiers
1. Known allergy or hypersensitivity to any component of ABSK131.
2. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
3. Another active primary malignancy.
4. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.
Trial design
Treatments tested in this trial
- ABSK131
Treatment groups
266 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov